Evaluation Patient Satisfaction After Passive Bladder Catheter Removal Compared to Active Removal

Official title

Multicenter, Randomized, Controlled Trial Evaluating Patient Satisfaction After Passive Bladder Catheter Removal Following Urological Surgery Compared to Active Removal by a Nurse

Overview

In usual practice, the removal of the bladder catheter is performed by a nurse a few days after the surgery. The nurse deflates the balloon and removes the catheter from the urethra by manual traction. To date, there are no solid data on the impact of passive catheter removal on patient satisfaction. It is therefore necessary to estimate the effect on patient satisfaction of active catheter removal by a nurse versus passive catheter removal under gravity. The effect on pain and anxiety will also be compared between the two techniques. The methodology used was that of an open-label randomized controlled trial.

Interventions

• Procedure Passive indwelling urinary catheter removal
  After washing the patient's perineal area with water and mild soap, the nurse deflates the indwelling urinary catheter balloon and instructs the patient to take a shower (standing). During this time, the catheter will fall under gravity.
• Procedure Active indwelling catheter removal by a nurse
  After washing the patient's perineal area with water and mild soap, the nurse deflates the balloon and removes the catheter from the urethra by manual traction.

Primary outcome measures

• Patient satisfaction score [Time frame: Within one hour after indwelling urinary catheter removal at day 0]

Secondary outcome measures (4)

• The pain experienced by patients [Time frame: Prior to catheter removal (within 30 minutes before the start of the procedure) and in the immediate aftermath (within one hour after the removal of the catheter)]
• The anxiety experienced by patients [Time frame: Prior to catheter removal (within 30 minutes before the start of the procedure) and in the immediate aftermath (within one hour after the removal of the catheter)]
• Patient satisfaction [Time frame: at Day 0, at Day 2, at Day 15]
• Patient satisfaction [Time frame: at Day 2, at Day 15]

Eligibility criteria

Inclusion criteria

• Male ≥ 18 years old
• With an indwelling urinary catheter placed after any of the following procedures:

A uro-endoscopic surgery from the list below:

• Endoscopic prostate resection (or transurethral prostate resection).
• Laser prostate enucleation
• Prostate thermotherapy by radiofrequency
• A high-intensity focused ultrasound treatment for prostate cancer
• Cervico-prostatic incision or internal urethrotomy
• Endoscopic/Transurethral Resection of Bladder Tumor (TURBT)
• Surgical treatment of bladder stones, ureter stones (rigid ureteroscopy) and kidney stones (flexible ureteroscopy with laser stone fragmentation)
• Patient who has given written consent to participate

Exclusion criteria

• Patient who is unable to perform intimate hygiene alone in a standing position
• Patient with a painful genital lesion
• Patient with an extended pelvic pathology
• Need to remove the indwelling urinary catheter at the patient's home instead of hospital
• Patient under guardianship or curator
• Patient unable to understand the objectives of the study or unwilling to comply with postoperative instructions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

France · 2 centers

• CHU Grenoble — Grenoble
• Hôpita Edouard Herriot — Lyon

Identifiers

NCT: NCT05313945 · 69HCL21_0171

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗